Inovio needs to get through a PII of one or two of their more promising vaccines before a big pharma will join them. This latest offering stinks for us holders but it's allowing Inovio to see these trials trials through completion. I don't think Inovio has any intention of going through a PIII without a partner. I'll be surprised if they get a partner before any PII are completed.
Inovio will have to complete a Phase IIb (which is Phase III enabling). The FDA pathway is very structured, but can be expedited. A Phase IIa would be escalating safety (ie., increasing the dose or increasing the frequency of administration) and demonstrating that there is no increased risk to the patient from escalating the dose. There is also the "secondary clinical criteria" that generally include some sort of demonstration that clinical efficacy is achieved. Since Inovio deals in vaccines, there is only a thresh hold dose. That is the dose at which an immune response occurs. Increasing the amount of a vaccine causes no greater immune response, hence they only need to identify the dose at which the immune system gets turned on. Usually one milligram of an antigen in a vaccine is a huge amount. The immune system has "memory" which is why the second dose produces a larger amount of circulating antibody. The antibody response has to be "neutralizing" which means it conbines with whatever the disease virus is and makes it large enough that the white blood cells, or the fixed macrophages in the liver and elsewhere, will engulf and clear the virus. But since there is competition for a Hep C vaccine, there is no expedited pathway. In other words several companies have started clinical trials and are hoping to get to a Phase III. There is actually one Phase III planned on clinicaltrialsDOTgov among the 60 plus studies that are "interventional" and at least Phase II. term